Chronic Functional ConstipationNCT06553664
The Efficacy of Long-Course Treatment Using Vibrating Capsules for Chronic Constipation
A study testing Treat with Vibrabot capsules for at least 7 weeks in people with Chronic Functional Constipation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Functional Constipation
- What is being tested?
- Treat with Vibrabot capsules for at least 7 weeks
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2023to 2 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 85-year-old men and women.
- Patients with symptoms of constipation in the six months prior to treatment, with less than three complete spontaneous bowel movements (CSBM) per week over the last three months, along with at least one of the following symptoms in at least 25% of bowel movements: Straining during defecation; Lumpy or hard stools (Bristol stool types 1-2) in at least 25% of bowel movements; A sensation of incomplete evacuation in at least 25% of bowel movements; A sensation of anorectal obstruction/blockage in at least 25% of bowel movements; Manual maneuvers to facilitate defecation (e.g., digital evacuation, pelvic floor support) in at least 25% of bowel movements. Loose stools are rarely present without the use of laxatives; insufficient criteria for irritable bowel syndrome Criteria fulfilled for the last three months with symptom onset at least six months prior to diagnosis.
- Patients with constipation not caused by organic disease based on medical history and previous medical records.
- Patients who agree to participate in the trial and voluntarily sign the informed consent form.
Who cannot join
- Patients who are not eligible for surgery or those who refuse any abdominal surgery.
- Patients with known or suspected gastrointestinal obstruction, stenosis, diverticula, bleeding, deformities, or fistulas.
- Patients allergic to polymer materials.
- Patients with cardiac pacemakers or gastrointestinal pacemakers.
- Patients with abdominal aortic aneurysm, gastrointestinal vascular diseases, ulcers, or bleeding tendencies.
- Patients with swallowing disorders.
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- Patients with severe depression or anxiety, or severe acute gastrointestinal diseases.
- Patients with history of gastrointestinal surgery or surgeries altering gastrointestinal structure (excluding appendectomy) or patients who underwent gastrointestinal endoscopic submucosal dissection (ESD) in the past three months.
- Patients with severe hemorrhoids (grade 3-4 as defined by the American Society of Colon and Rectal Surgeons guidelines).
- Patients planning to undergo magnetic resonance imaging (MRI) in the near future.
- Pregnant women or planning to become pregnant.
- Any other conditions deemed unsuitable for participation by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Long-Course Treatment Using Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) for Chronic Constipation
This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).
Read the detailed description
This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study.
After completing a baseline questionnaire on bowel movements over the most recent 2 weeks, participants took VC at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. After completion of treatment, subjects entered a follow-up period for at least 8 weeks. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks.
Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
- Conditions
- Chronic Functional Constipation
- Being tested
- Treat with Vibrabot capsules for at least 7 weeks
- Keywords
- Chronic Functional Constipation, Vibrating Capsule, Long-Course Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treat with Vibrabot capsules for at least 7 weeksDrug
Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week.
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Subjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. Receives: Drug: Treat with Vibrabot capsules for at least 7 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of responders during the treatment period.
Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period.
Measured: at least 7 weeks
Secondary outcomes (2)
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period.
Evaluating the proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period.
Measured: at least 7 weeks
Number of mean weekly complete spontaneous bowel movements (CSBM).
The average number of complete spontaneous bowel movements per week for each patient during the treatment period.
Measured: at least 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start28 Jul 2023
- Primary completion7 Oct 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Functional ConstipationStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jiangxuan, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Xuan Jiang, Professor, Principal investigator, Beijing Tsinghua Changung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553664
- Sponsor's protocol ID
- Long-Course Treatment
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Long-Course Treatment Using Disposable Gastrointestinal Vibrating Capsule (Vibrabot Capsule) for Chronic Constipation
- ClinicalTrials.gov ID
- NCT06553664
- Acronym / sponsor ID
- Long-Course Treatment
- Conditions
- Chronic Functional Constipation
- Keywords
- Chronic Functional Constipation, Vibrating Capsule, Long-Course Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 7 Oct 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).
Detailed description
This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria and does not meet any of the exclusion criteria, the subject is considered eligible for admission to the study.
After completing a baseline questionnaire on bowel movements over the most recent 2 weeks, participants took VC at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. After completion of treatment, subjects entered a follow-up period for at least 8 weeks. During the study period, the subjects are required to keep an e-diary recording daily bowel movements (BMs), medication intake, and discomforts, and complete the Patient Assessment of Constipation Symptoms (PAC-SYM) and the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaires every two weeks.
Subjects are not expected to change their diet or lifestyle during the study. If the subject has not had a bowel movement for three or more consecutive days, the subject is allowed to use another method of defecation to assist with defecation. Subjects are required to avoid antibiotics, probiotics, prebiotics, and proton pump inhibitors throughout their participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Drug: Treat with Vibrabot capsules for at least 7 weeksSubjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 85-year-old men and women.
- Patients with symptoms of constipation in the six months prior to treatment, with less than three complete spontaneous bowel movements (CSBM) per week over the last three months, along with at least one of the following symptoms in at least 25% of bowel movements: Straining during defecation; Lumpy or hard stools (Bristol stool types 1-2) in at least 25% of bowel movements; A sensation of incomplete evacuation in at least 25% of bowel movements; A sensation of anorectal obstruction/blockage in at least 25% of bowel movements; Manual maneuvers to facilitate defecation (e.g., digital evacuation, pelvic floor support) in at least 25% of bowel movements. Loose stools are rarely present without the use of laxatives; insufficient criteria for irritable bowel syndrome Criteria fulfilled for the last three months with symptom onset at least six months prior to diagnosis.
- Patients with constipation not caused by organic disease based on medical history and previous medical records.
- Patients who agree to participate in the trial and voluntarily sign the informed consent form.
Key exclusion criteria (12 listed)
- Patients who are not eligible for surgery or those who refuse any abdominal surgery.
- Patients with known or suspected gastrointestinal obstruction, stenosis, diverticula, bleeding, deformities, or fistulas.
- Patients allergic to polymer materials.
- Patients with cardiac pacemakers or gastrointestinal pacemakers.
- Patients with abdominal aortic aneurysm, gastrointestinal vascular diseases, ulcers, or bleeding tendencies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treat with Vibrabot capsules for at least 7 weeksSubjects in the trial group took Vibrabot capsules at least 7 weeks, doses ranging from 2 to 5 capsules orally per week. | Drug | Trial group |
Primary outcome
The proportions of responders during the treatment period.
Time frame: at least 7 weeks
Responders are the subjects with an average increase of ≥1 complete spontaneous bowel movements (CSBMs) per week during the treatment period compared to the baseline period.
2 secondary outcomes
The proportion of patients with complete spontaneous defecation (CSBM) ≥three times per week during the treatment period.
Time frame: at least 7 weeks
Number of mean weekly complete spontaneous bowel movements (CSBM).
Time frame: at least 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuan Jiang, Professor principal investigator
Beijing Tsinghua Changung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treat with Vibrabot capsules for at least 7 weeks in people with Chronic Functional Constipation, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportions of responders during the treatment period. (time frame: at least 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.